Duns Number:109903521
Device Description: REDAPT SLEEVELESS MONOLITHIC REVISION STEM 190MM SIZE 2 REDAPT SLEEVELESS MONOLITHIC REVISION STEM 190MM SIZE 27 STANDARD OFFSET
Catalog Number
71354477
Brand Name
REDAPT
Version/Model Number
71354477
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151902
Product Code
LZO
Product Code Name
Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
Public Device Record Key
3d13e778-da26-4f2b-9d2d-b2355a6365c0
Public Version Date
November 03, 2020
Public Version Number
4
DI Record Publish Date
December 17, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 10651 |
2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
3 | A medical device with high risk that requires premarket approval | 351 |